Document 3Zk8zDnqGxvoD6gdZmMneRga

Message From: Sent: To: CC: Subject: AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBO HF23SPDLT)/CN =RECIPIENTS/CN =FA78 B98923384078995E04A73D258D83-AlRACTION] 4/2/2025 11:42:11 AM Steve Walter [swalter@asocorp.com] Douglas Parzuchowski [dparzuchowski@isl-fl.corn] CORRECTION: Updated email address for CBI related to the Presidential Exemption In the previous email, an incorrect email address was provided for the submission of electronic Confidential Business Information (CBI). The email address should be: OA(PS CB1(ir eni.i2;O` Thank you. From: AirAction Sent: Friday, March 28, 2025 10:28 AM To: Steve Walter <swalter@asocorp.com> Cc: Douglas Parzuchowski <dparzuchowski@isl-fl.com> Subject: RE: Sterilizer Rule (89 FR 24090): [International Sterilization Laboratory] Thank you for emailinv. the AirAction mailbox to request a Presidential Exemption under section 1 12(i)(4) of the Clean Air Act and for engaging with EPA in advancing President Trump's Executive Orders and Powering the Great American Comeback. We have received your email and will be in contact soon. If you have Confidential Business Information (CBI) that you'd like to submit, please submit it in electronic version to the (.Bl.ir`:pa.il.(.1\ inbox or in hardcopy to: USEPA. OAQPS CORE CBI Office 4930 Old Page Road Durham, NC 27703 From: Steve Walter <swa Iter@a socorp.com > Sent: Wednesday, March 26, 2025 11:53 AM To: AirAction <AirAction@epagov> Cc: Douglas Parzuchowski <ciparzuchowski@isl -fl.com > Subject: Sterilizer Rule (89 FR 24090): [International Sterilization Laboratory] Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. I To: di Re: Sterilizer Rule (89 FR 24090): International Sterilization Laboratory I write on behalf of [international Sterilization Laboratory] to request that the President issue a two-year exemption pursuant to his authority under CAA Section 1 12(i)(4) for all emission standards and associated requirements set or revised in EPA's April 4, 2024 National Emission Standardslie Hazardous Air Pollutants: Ethylene Oxide Emissions ,S'iandardsfie Sterilization Facilities Residual Risk and Technology Review, 89 FR 24090 (April 5, 2024) (Sterilizer Rule). Sierra Club FOIA 2025-EPA-04883 ED_018388_00005593-00001 SC_EVERSPLIT0020806 International Sterilization Laboratory requests that the Presidential Exemption apply to the following facilities regulated by the Sterilizer Rule and all sources therein: International Sterilization Laboratory, 217 Sampcy Road, Groveland, Florida, 34736 International Sterilization Laboratory requests that the President issue a two-year exemption as quickly as possible, but designate it as taking effect on the compliance deadlines for the standards in the Sterilizer Rule. Specifically: For standards set or revised under CAA Section 112(f) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 6, 2026 (the compliance deadline for those standards); For standards set or revised under CAA Section 112(d) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 5, 2027 (the compliance deadlines for those standards). As explained further in the attached letter submitted to EPA on March 17 on behalf of the Ethylene Oxide Sterilization Association (FOSA), the technology necessary to implement the standards is not available because manufacturers cannot guarantee that existing emissions control equipment will enable sources to meet the new standards; there is not a sufficient supply of the necessary technology; and there are not enough experienced installation professional and technical experts to install and test that equipment within the current compliance timeframes. As also explained further in FOSA's March 17 letter, it is in the national security interests of the United States to issue the requested exemption because if some facilities choose to cease operations rather than attempt compliance (which is likely), that will disrupt the supply of sterilized medical devices, raise the cost of those devices, and/or force medical suppliers or providers to source sterilized medical devices from abroad. Please don't hesitate to let me know if any additional information is needed. [International Sterilization Laboratory] appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible. Sincerely, Steve Walter Vice President ISL International Sterilization Laboratory Phone: 941-378-6649 Cell: 813-843-2124 Email: swalter@ISL-FL.com NOTICE This e-mail may contain confidential information It is intended only for the use of the person(s) named above If you have received this e-mail in error; you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited If you are not the intended recipient, please notify us immediately by reply e-mail, destroy all copies of the message, and delete the message from your system Unless stated to the contrary, any opinions or comments contained in the e-mail are personal to the writer and do not represent the official view of the company Thank you for your cooperation Although this email and any attachments are believed to be free of any VIRUS or other defect that might affect any computer system into which it is received and opened, it is the responsibility of the recipient to ensure that it is virus free and ASO Corporation, ASO LLC, its officers, directors, affiliates, agents, and employees accept no responsibility for any Joss or damage Sierra Club FOIA 2025-EPA-04883 ED_018388_00005593-00002 SC_EVERSPLIT0020807